Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis

Hill Dermaceuticals

Status and phase: Completed; Phase 2

Conditions: Otomycosis

Treatments: Drug: 14-Day Miconazole Oil (Miconazole 2%); Drug: 7-Day Miconazole Oil (Miconazole 2%); Drug: 14-Day Placebo - Oil Vehicle

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03130738

HD-MCZ-PHII-DRF062016

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.

Full description

Miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as Candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. The 2% formulation of miconazole is commonly used for dermatophytic infections. The mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the US.

Miconazole targets the cytochrome P450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. Because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth.

In addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.

Enrollment: 65 patients

Sex: All

Ages: 25+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncomplicated otomycosis of the external ear only, age more than 2 year

Exclusion criteria

• Pregnancy
• Other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s)
• Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated
• Previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s) that had been removed and had completely healed
• Previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry
• Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry
• Recurrent otomycosis that had been unresponsive to previous antifungal treatment
• Known hypersensitivity to any of the components in the test formulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 3 patient groups, including a placebo group

7-Day Miconazole Oil (Miconazole 2%)

Active Comparator group

Description:

7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

Treatment:

Drug: 7-Day Miconazole Oil (Miconazole 2%)

14-Day Miconazole Oil (Miconazole 2%)

Active Comparator group

Description:

14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

Treatment:

Drug: 14-Day Miconazole Oil (Miconazole 2%)

14-Day Placebo - Oil Vehicle

Placebo Comparator group

Description:

14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient

Treatment:

Drug: 14-Day Placebo - Oil Vehicle